MANI Quality Control in Hematology Analysers

Dr. P.G.
Subramanian
Hematopathology laboratory
Tata Memorial Hospital
Laboratory test results
Clinical diagnosis
Patient management
A subjective term for which each person has
his or her own definition.
In technical usage, quality can have two
meanings:
The characteristics of a product or service that
bear on its ability to satisfy stated or implied
needs
A product or service free of deficiencies."
[5]
Quality Assuarance
Prevention of defects/errors
Quality Control
Detection of errors/defects
Quality is assured at
Pre-analytical phase
Analytical phase
Post analytical phase
The Quality Assurance Cycle
Testing &
Sample
Transport
Quality Control
Customer
Service
Patient/Client
Preparation
Sample
Collection
Sample Receipt
& Accessioning
Record Keeping
Reporting
XYZ Laboratory
Address -------------------------
Tel: --------------, Fax: ---------------
Examination Request Form
Patient name: ________________________________________
Date of Birth/Age:____________________________________
Sex: ________________ Unique ID of patient______________
Referring Doctor name:__________________________________
Address:_______________________________________________
_____________________________________________________________
Primary Sample Type: Blood/Fluid/Sputum/Stool/Microbiological Specimen/Slides/Tissue/__________________________ (Any other specify)
Date and Time of Primary Sample Collection: ___________________________________________________________________________
Date and Time of Receipt of Primary Sample by the Laboratory: _______________________________________________________
Clinical History of the patient:
__________________________________________________
____________________________________________________
Treatment History of Patient:
__________________________________________________
____________________________________________________
Examinations Requested :_____________________________________________________________________________
___________________________________________________________________________________________________
___________________________________________________________________________________________________
___________________________________________________________________________________________________
Signature ______________
Request form shall contain
ISO15189 Cl. 5.4
Verify the identity of the patient
Do venipuncture in a proper manner
Collect appropriate amount in the
appropriate anticoagulant
Proper recording of the identity of the
person collecting the sample
A serious, and potentially fatal, cause of
mishap is collection from the wrong patient
or subsequent specimen mix-up or
transcription error. These can occur at any
stage. It is essential to have a cross-check
procedure.
The samples should be transported into trays
having protective covering and providing
suitable environment required preventing
deterioration of the sample. The person
carrying the sample should be following the
universal safety norms.
Clotted sample
Inadequate sample
Hemolysed sample
Mismatch in patient and sample identity
Improper anticoagulant or additive use
Analysis of various reasons for sample
rejections can generate a set of data which
might reflect the highest probability of
chance of pre-analytical errors due to which
the samples were rejected.
A feedback of this kind to the concerned
ward of the hospital may enhance a positive
attitude towards quality improvement at
pre-analytical stage.
Quality Indicator Feedback shall be monitored on periodic
basis for continual improvement
Internal quality control (IQC),
External quality assessment scheme (EQAS)
and
Standardization.
(6)
(6) International Council for Standardization in Hematology
Flow of
diagnostic work
Drift checks
Accuracy transfers
Drift checks
EQA distributions
LETS UNDERSTAND FEW
IMPORTANT TERMS
NOW
Definition
Precision refers to the
reproducibility of a result.
Comparing QC terms to a
target Figure illustrates
that the results are precise
(close together) but not
accurate (they are not in
the bulls-eye).
Checking precision is
required while
-calibration
-troubleshooting
Definition
Closeness of a result to
the true (accepted)
value.
NOTE: Before
determining accuracy,
first determine
precision.
Comparing QC terms to
a target Figure
illustrates that the
results are accurate (in
the bulls-eye) and
precise (close together).
NOTE
You cannot have
accuracy without
precision.
However, you can have
precision without
accuracy.
This figure illustrates
that the results are
neither accurate nor
precise.
None of the results
are close together,
and none of them are
in the bulls-eye.
Calibration
Carry over check
Linearity check
Calibration
Is done to standardize the instrument
for accuracy.
Calibrator
Certified Reference Material (CRM) used to
calibrate a measurement on an analyzer.
Cal-Factors
If any deviation from calibration references is
observed necessary calibration correction factors
are applied to set the accuracy of the instrument.
Carryover is defined
as a number of cells
remaining behind
following the cycling
of a blood sample.
This test is
performed to
determine if one
sample interferes
with the accurate
analysis of the next
sample.
Ideally, carryover
Shall be very low.
Measure a specimen with a high
concentration in triplicate,
immediately followed by a
specimen with a low
concentration in triplicate.
Where l
1
and l
3
are the results of
the first and third
measurements of the samples
with a low concentration and h
3
is the third measurement of the
sample with a high
concentration.
Establishes the range for reporting of values
if the total WBC count is 200 x 10
9
/L
If the upper limit of linearity of the analyzer
is 100 x 10
9
/L
Then the sample has to be diluted and re run
to get accurate values of total WBC count
when diluted 1in 4 and run the analyzer will
give a value of 75 x 10
9
/L which might
indicate that true value is 300 x 10
9
/L
How many? -1, 2, 3
Which levels? low, normal, high
How frequently Daily, every 8hr, every hour
What should we look for in a control
Atleast 2 levels
CBC - low and normal
Coagulation (PT and APTT) normal and high
Coagulation (Factor Assays) low and normal
Frequency at least 8
th
hourly (for 24 hr service)
or once a day
=
Mean ( ) is the sum of all the
measurements () divided by the number of
measurements (n)
Formula = x
i
/ n
Where
x
i
= each data point
n = the number of
data points in the set
=
Mean describes the central tendency of
the data set.
In clinical lab, the mean identifies the
target value of a set of data points, usually
QC or patient data.
Standard deviation (SD)
SD quantifies the degree of dispersion of
data points about the mean.
SD is used to set limits upon which control
result acceptability is determined.
Formula of standard deviation
Normal Distribution Curve
or
Gaussian curve
Describes events or data
that occur symmetrically
about the mean.
Out of 100 events
68.7 will fall within 1 SD
How to calculate +1 SD, +2 SD, +3 SD & -1 SD, -2 SD, -3 SD
Mean + (1 x SD) = + 1SD
Mean + (2 x SD) = + 2SD
Mean + (3 x SD) = + 3SD
Mean - (1 x SD) = - 1SD
Mean - (2 x SD) = - 2SD
Mean - (3 x SD) = - 3SD
Coefficient of variation (CV)
CV is another way of indicating standard deviation, related to
the actual measurement, so that variation at different levels
can be compared.
Formula
It is expressed as a percentage (%CV).
CBC parameters Acceptable
%CV
WBC
(White blood cell count)
4.0 %
RBC
(Red blood cell count)
3.0 %
Hemoglobin 3.0 %
MCV
(Mean corpuscular cell
volume)
2.0 %
Platelet 9 %
Quality Indicator %CV shall be monitored on periodic
Improved
%CV
3%
2.5%
2.5%
1.5%
7%
Manually by using
arithmetic graph paper.
MS Excel Software in
computer.
Software like
MedLab QC
Inbuilt QC program in the

analyzers.
(7) Levey S, J ennings ER: The use of control charts in the clinical
laboratory. American Journal of Clinical Pathology 1950; 20:1059-1066.
Westgard s Rules
Control rules decide whether an analytical run is in-control
or out-of-control.
"Westgard rules" are used when one control material is
analyzed.
A run is rejected when a single control
measurement exceeds the mean plus 3SD or
the mean minus 3SD control limit.
This rule is used as a warning rule to trigger careful
inspection of the control data by the following
rejection rules.
2
2s
- reject when 2 consecutive control
measurements exceed the same mean plus 2SD or
the same mean minus 2SD control limit.
R
4s
- reject when 1 control measurement in a group
exceeds the mean plus 2SD and another exceeds
the mean minus 2SD.
4
1s
measurements exceed the same mean plus 1SD or
the same mean minus 1SD control limit.
10
x
measurements fall on one side of the mean.
8
x
Modification of 10
x
12
x
Modification of 10
x
7
T
- reject when seven control measurements
trend in the same direction, i.e., get
progressively higher or progressively lower.
Look for a "trend"
Summary of L-J Interpretation
First step
Start up status and background count check
(Monitor for acceptable background..if required take corrective
action)
Done once
QC monitoring using multilevel controls
(Low level, normal level and high
level) (Monitor L-J chart, apply Westergards
interpretation, monitor %CV..if required take corrective action)
Periodic in b/w
check till shut
down
QC monitoring using retained sample
(Monitor %CV..if required take corrective action)
Inform the supervisory staff.
Check the QC material open vial expiry date, discoloration,
expiry date.
Check the temperature of the refrigerator in which the
control material was kept.
Check the reagent (expiry date, opening date etc.)
Check the instrument status. (check priming, dispensing
etc.)
Rerun the controls.
Run the normal retained sample.
If problem persists run the fresh controls.
If problem still persists call the engineer and also refer
manufacturers troubleshooting guide.
And many more can be included / excluded depending on the laboratory set up.
Comparative study (Z-Score)
Monitoring of Population mean (Bulls
algorithm)
Rerun on same analyzer in special
mode Rerun on another analyzer
Correlation with peripheral smears
Delta checks
Probable criteria
when peripheral
smear is made
All new cases of
leukemia.
New cases of Bicytopenia
/ pancytopenia :
Hemoglobin < 10 gm%
Total Leukocyte Count <4 x
10
9
/L
Platelet Count < 100 x 10
9
/L
Total Leukocyte
Count or Platelet
Count vote out even
after rerun.
Absolute basophilia
in any new case > 0.1
x 10
9
/L
Absolute
monocytosis in any
new case > 1 x
10
9
/L
Absolute
lymphocytosis in
any new case > 5 x
10
9
/L
Blast flag in the scatter plot in any new
case.
Platelet clump flag and PIC/POC
(Plt count <100).
Malaria like picture in the scatter plot.
A - 1 A - 2 A - 3 A - 4 A - 5 A - 6 A - 7 A - 8 A - 9 A-10 A-11 A-12 MEAN SD
WBC 5.9 6.3 6.2 5.2 6.3 6.2 5.9 6.3 6.2 5.9 6.3 6.2 6.1 0.3
HGB 13.1 12.9 12.7 13.1 12.9 12.7 13.1 12.9 12.7 13.1 12.9 12.7 12.9 0.2
PLT 262 246 255 262 246 255 262 246 300 262 246 255 258.1 14.9
Z-
SCORE A - 1 A - 2 A - 3 A - 4 A - 5 A - 6 A - 7 A - 8 A - 9 A-10 A-11 A-12
WBC -0.55 0.70 0.39 -2.74 0.70 0.39 -0.55 0.70 0.39 -0.55 0.70 0.39
HGB 1.17 0.00 -1.17 1.17 0.00 -1.17 1.17 0.00 -1.17 1.17 0.00 -1.17
PLT 0.26 -0.81 -0.21 0.26 -0.81 -0.21 0.26 -0.81 2.82 0.26 -0.81 -0.21
Z SCORE SCALING :-
< 0.5 - Excellent performance
0.5 to 1.0 - Satisfactory
1 to 2 - Acceptable
> 2 - Defect requiring attention
Z-Score
CBC/
peripheral smears/
reticulocyte count
Nodal
org. -
AIIMS,
New
Delhi
Contact
person - Dr.
Renu
Saxena
Coagulation studies
Nodal org. - CMC, Vellore
Contact person - Dr. Alok Srivastav
Check for the IQC results during
the period when the EQAS
sample was analyzed.
Follow the instructions from the
nodal organization.
ISO 15189, Clause 5.8 says -
Laboratory results shall be
Unambiguous & Meaningful relevant to the clinical
problem
The report shall contains at least the following information:
ISO 15189:2007 Clause 5.8.3 (a to q)
clear, unambiguous identification of the examination including, where appropriate, the measurement
procedure
the identification of the laboratorythat issued the report
unique identification and location of the patient, where possible, and destinationof the report
name or other unique identifier of the requester and the requesters address
date and time of primary sample collection, when available and relevant to patient care, and time of
receipt by the laboratory
date and time of release of report which if not on the report shall be ready accessible when needed
source and system (or primary sample type)
results and examinations reported in SI unitsor units traceable to SI units where applicable
biological reference interval, where applicable
interpretation of results, where appropriate
other comments (e.g. quality or adequacy of samples which may have compromised with the result,
etc)
identification of the person authorizing the release of results
if relevant, original and corrected results
signatureof authorization of the person checking or releasing the report is received.
A formal way of testing for aberrant results is known as `delta check`. The
blood count parameters should not differ from recent tests in the previous 2-
3 weeks by more than a certain amount.
The difference should generally be not more than:
For Hb and RBC For WBC For Platelet count
10 % 20-25 % 50 %
Delta check must be done before dispatch of the report.
This is only possible if the previous report of the patient and the
clinical condition is provided.
Assuming that the patients clinical
condition has not altered significantly
Each and every result generated is scrutinizedand
authenticated by the staff running the sample.
The person at the dispatch counter delivers the
reports to the identified individual.
The receivers identity, name and signature are
taken and the time and date of dispatch is recorded
in the register.
Quality Indicator TAT shall be monitored on periodic
TAT
BMA-
3wd
Coag-
4 hrs
CBC-
2hrs
The requester i.e.
the clinician is
notified in case of
delay in
examination only
in such cases
where the delay
can compromise
patients care.
The laboratory
takes
responsibility for
reporting the
results within the
specified turn
around time.
Reliable
Timely
Cost effective
Laboratory test results
Query's and suggestions
are welcome

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Dr. P.G.

Inbuilt QC program in the

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